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A Study of CDI-31244: A Novel NNI in HV and HCV Infected Subjects

Primary Purpose

Hepatitis C

Status

Completed

Phase

Phase 1

Locations

Canada

Study Type

Interventional

Intervention

CDI-31244

Placebo

About this trial

This is an interventional treatment trial for Hepatitis C focused on measuring non-nucleoside inhibitor, NNI, HCV, DAA

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Main Inclusion Criteria:

HV and HCV INFECTED SUBJECTS:

Male or female aged ≥ 18 to ≤ 65 years;
Body mass index ≥ 18.5 to ≤ 35.0 kg/m2;
Body weight ≥ 50 kg;
Negative screening for alcohol and drugs of abuse;
Normal results on 12-lead electrocardiogram (ECG);
For females, negative result on a pregnancy test.

HCV INFECTED SUBJECTS:

HCV treatment-naïve subjects must have not received prior direct acting agent (DAA) treatment for hepatitis C infection;
Documented clinical history compatible with chronic hepatitis C;
HCV Genotype 1 by HCV genotyping performed at Screening;
Plasma HCV RNA ≥ 5.0 log10 IU/mL at Screening;
Laboratory evidence of no cirrhosis (negative liver biopsy or fibroscan or FibroTest, F2 or lower) within one year prior to study), if these are not available, do a FibroTest at screening, which must be F2 or lower.

Main Exclusion Criteria:

HV and HCV INFECTED SUBJECTS:

Females who are pregnant or are lactating;
Co-infected with hepatitis B virus (HBV, HBsAg positive) and/or human immunodeficiency virus (HIV);
Abuse of alcohol and/or drugs that could interfere with adherence to study requirements as judged by the investigator;
Positive screen result for drugs of abuse or alcohol on Day -1. Use of other investigational drugs within 60 days of dosing;
Subject with intestinal malabsorption;
Presence of out-of-range cardiac interval on the screening ECG or other clinically significant ECG abnormalities;
Serum creatinine > upper limit of normal (ULN);
Any clinically significant medical condition that, in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results.

HEALTHY VOLUNTEERS:

Positive screen for anti-HCV antibody

HCV INFECTED SUBJECTS:

Clinical (in the opinion of the investigator) or laboratory evidence of cirrhosis;
History or signs of decompensated liver disease: ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, or other clinical signs of portal hypertension or hepatic insufficiency;
History of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC;
Active clinically significant diseases.

Sites / Locations

Algorithme

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm Type

Experimental

Arm Label

Cohort 1A HV

Cohort 2A HV

Cohort 3A HV

Cohort 4A HV

Cohort 5A HV

Cohort 6A HV

Cohort 7A HV

Cohort 8A HV

Cohort 1B HCV genotype (GT) 1

Cohort 2B HCV GT 1

Cohort 3B HCV GT 1

Arm Description

CDI-31244 20 mg active or placebo single dose (SD)

CDI-31244 50 mg active or placebo SD

CDI-31244 100 mg active or placebo SD

CDI-31244 200 mg active or placebo SD; food effect

CDI-31244 400 mg active or placebo SD

CDI-31244 200 mg active or placebo multiple dose (MD)

CDI-31244 200 mg active or placebo MD

CDI-31244 400 mg active or placebo MD

CDI-31244 600 mg active or placebo MD

CDI-31244 800 mg active or placebo MD

Outcomes

Primary Outcome Measures

Number of treatment emergent adverse events (AE)

The safety and the tolerability of single and multiple oral doses of CDI-31244 through number of AEs observed in HV and HCV infected subjects

Secondary Outcome Measures

Measure plasma levels of CDI-31244 after SD

Plasma levels of CDI-31244 in the the single dose HV cohorts

Measure plasma levels of CDI-31244 after SD in fasted and fed conditions

The effect of food on the plasma levels of CDI-31244 in the single dose HV cohorts

Measure plasma levels of CDI-31244 after MD

Plasma levels of CDI-31244 in the multiple dose HV and HCV infected cohorts

Measure HCV viral load through the RNA quantitative test

The clinical efficacy of CDI-31244 in HCV-infected subjects as measured by the maximal change in antiviral activity through changes in the HCV RNA load

Measure HCV mutation through genotyping at baseline and after CDI-31244 dosing

The possible emergence of hepatitis C virus resistance mutation in HCV infected subjects

Full Information

NCT ID

NCT02760758

First Posted

April 27, 2016

Last Updated

April 19, 2021

Sponsor

Cocrystal Pharma, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02760758

Brief Title

A Study of CDI-31244: A Novel NNI in HV and HCV Infected Subjects

Official Title

A Phase Ia/Ib Study Assessing Single and Multiple Doses of CDI-31244: A Non-Nucleoside Inhibitor in Healthy and Hepatitis C Virus-Infected Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Completed

Study Start Date

April 2016 (undefined)

Primary Completion Date

March 2017 (Actual)

Study Completion Date

April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cocrystal Pharma, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This is a First in Human study of orally administered CDI-31244, a non-nucleoside inhibitor (NNI) in healthy volunteers and HCV infected individuals

Detailed Description

This is a single center, double-blind, placebo-controlled, randomized, single ascending oral dose and multiple oral dose design, incorporating fed/fasted comparisons. The study will include two groups: Group A - single ascending dose (SAD) including a food effect cohort, and multiple dose (MD) in healthy volunteers (HV), and Group B MD in Hepatitis C Virus (HCV) infected individuals divided in two parts. Five single-dose cohort are planned. For the five single-dose cohorts, a sentinel group of 2 subjects will be dosed at least one day prior to enrolling remaining subjects. Six multiple-dose cohorts are planned. Three multiple dose cohorts in healthy volunteers and three cohorts in HCV-infected individuals. The dosing of Group B will be conducted following safety and pharmacokinetic (PK) review of Group A. The dosing of Group B, Part 2 will be conducted only if Part 1 shows acceptable safety and efficacy results.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C

Keywords

non-nucleoside inhibitor, NNI, HCV, DAA

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

76 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1A HV

Arm Type

Experimental

Arm Description

CDI-31244 20 mg active or placebo single dose (SD)

Arm Title

Cohort 2A HV

Arm Type

Experimental

Arm Description

CDI-31244 50 mg active or placebo SD

Arm Title

Cohort 3A HV

Arm Type

Experimental

Arm Description

CDI-31244 100 mg active or placebo SD

Arm Title

Cohort 4A HV

Arm Type

Experimental

Arm Description

CDI-31244 200 mg active or placebo SD; food effect

Arm Title

Cohort 5A HV

Arm Type

Experimental

Arm Description

CDI-31244 400 mg active or placebo SD

Arm Title

Cohort 6A HV

Arm Type

Experimental

Arm Description

CDI-31244 200 mg active or placebo multiple dose (MD)

Arm Title

Cohort 7A HV

Arm Type

Experimental

Arm Description

CDI-31244 200 mg active or placebo MD

Arm Title

Cohort 8A HV

Arm Type

Experimental

Arm Description

CDI-31244 400 mg active or placebo MD

Arm Title

Cohort 1B HCV genotype (GT) 1

Arm Type

Experimental

Arm Description

CDI-31244 400 mg active or placebo MD

Arm Title

Cohort 2B HCV GT 1

Arm Type

Experimental

Arm Description

CDI-31244 600 mg active or placebo MD

Arm Title

Cohort 3B HCV GT 1

Arm Type

Experimental

Arm Description

CDI-31244 800 mg active or placebo MD

Intervention Type

Drug

Intervention Name(s)

CDI-31244

Other Intervention Name(s)

CC-31244

Intervention Description

NNI

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

CDI-31244 Placebo

Intervention Description

no active ingredients

Primary Outcome Measure Information:

Title

Number of treatment emergent adverse events (AE)

Description

The safety and the tolerability of single and multiple oral doses of CDI-31244 through number of AEs observed in HV and HCV infected subjects

Time Frame

Day 1 to Day 35

Secondary Outcome Measure Information:

Title

Measure plasma levels of CDI-31244 after SD

Description

Plasma levels of CDI-31244 in the the single dose HV cohorts

Time Frame

Day 1 to Day 6

Title

Measure plasma levels of CDI-31244 after SD in fasted and fed conditions

Description

The effect of food on the plasma levels of CDI-31244 in the single dose HV cohorts

Time Frame

Day 1 to Day 13

Title

Measure plasma levels of CDI-31244 after MD

Description

Plasma levels of CDI-31244 in the multiple dose HV and HCV infected cohorts

Time Frame

Day 1 to Day 13

Title

Measure HCV viral load through the RNA quantitative test

Description

The clinical efficacy of CDI-31244 in HCV-infected subjects as measured by the maximal change in antiviral activity through changes in the HCV RNA load

Time Frame

Day 1 to Day 35

Title

Measure HCV mutation through genotyping at baseline and after CDI-31244 dosing

Description

The possible emergence of hepatitis C virus resistance mutation in HCV infected subjects

Time Frame

Day 1 to 35

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Main Inclusion Criteria: HV and HCV INFECTED SUBJECTS: Male or female aged ≥ 18 to ≤ 65 years; Body mass index ≥ 18.5 to ≤ 35.0 kg/m2; Body weight ≥ 50 kg; Negative screening for alcohol and drugs of abuse; Normal results on 12-lead electrocardiogram (ECG); For females, negative result on a pregnancy test. HCV INFECTED SUBJECTS: HCV treatment-naïve subjects must have not received prior direct acting agent (DAA) treatment for hepatitis C infection; Documented clinical history compatible with chronic hepatitis C; HCV Genotype 1 by HCV genotyping performed at Screening; Plasma HCV RNA ≥ 5.0 log10 IU/mL at Screening; Laboratory evidence of no cirrhosis (negative liver biopsy or fibroscan or FibroTest, F2 or lower) within one year prior to study), if these are not available, do a FibroTest at screening, which must be F2 or lower. Main Exclusion Criteria: HV and HCV INFECTED SUBJECTS: Females who are pregnant or are lactating; Co-infected with hepatitis B virus (HBV, HBsAg positive) and/or human immunodeficiency virus (HIV); Abuse of alcohol and/or drugs that could interfere with adherence to study requirements as judged by the investigator; Positive screen result for drugs of abuse or alcohol on Day -1. Use of other investigational drugs within 60 days of dosing; Subject with intestinal malabsorption; Presence of out-of-range cardiac interval on the screening ECG or other clinically significant ECG abnormalities; Serum creatinine > upper limit of normal (ULN); Any clinically significant medical condition that, in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results. HEALTHY VOLUNTEERS: Positive screen for anti-HCV antibody HCV INFECTED SUBJECTS: Clinical (in the opinion of the investigator) or laboratory evidence of cirrhosis; History or signs of decompensated liver disease: ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, or other clinical signs of portal hypertension or hepatic insufficiency; History of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC; Active clinically significant diseases.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Judy Pattassery

Organizational Affiliation

Cocrystal Pharma, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Algorithme

City

Montreal

State/Province

Quebec

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

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A Study of CDI-31244: A Novel NNI in HV and HCV Infected Subjects

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